FDA Registration
Active
🇺🇸 United States
MASTEL SURGICAL INC.
Reg #: 2184066
·
FEI: 1000115761
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- MASTEL SURGICAL INC.
- Registration Number
- 2184066
- FEI Number
- 1000115761
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1550 Samco Rd
- City
- RAPID CITY
- State
- SD
- ZIP
- 57702
- Country
- US
Owner / Operator
- Firm Name
- MASTEL SURGICAL INC.
- Operator Number
- 9005641
- Address
- 1550 SAMCO RD, --
- City
- Rapid City
- State
- SD
- Postal Code
- 57702
- Country
- US
- Correspondent
- Steve - Sharpless
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-07-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-09-22 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1992-06-26 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1992-06-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-09-22 |
Proprietary Names
SteriBest Sterilization Tray; Mesh Tray
Latch Accessory For Instrument Tray
K-WIRE RACK
MICROMETER CONTROL
OPTICAL ZONE MARKERS
Pouch Rack; SteriBest; Stringer
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device
Manufacture Medical Device